Efficacy and Safety of Dorner Tablets and Aspirin for Prevention of Arteriosclerosis Progress in Type 2 Diabetes Mellitus Patients

Overview

The objective was to evaluate the efficacy and safety of combination of beraprost and aspirin for prevention of arteriosclerosis progress in type 2 diabetes mellitus patients.

Full Title of Study: “Combination of Beraprost Sodium Tablets (Dorner) and Aspirin for Prevention of Arteriosclerosis Progress in Type 2 Diabetes Mellitus Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2013

Interventions

  • Drug: Beraprost
    • Oral
  • Drug: Aspirin
    • Oral

Arms, Groups and Cohorts

  • Experimental: Beraprost sodium tablet and Aspirin combination group
    • Oral
  • Experimental: Aspirin Group
    • Oral

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in carotid intima-media thickness
    • Time Frame: Baseline to Year 3
  • Incidence and severity of treatment-emergent adverse events
    • Time Frame: Up to 3 years
  • Safety assessed by vital signs: body temperature
    • Time Frame: Up to 3 years
  • Safety assessed by vital signs: pulse rate
    • Time Frame: Up to 3 years
  • Safety assessed by vital signs: respiratory rate
    • Time Frame: Up to 3 years
  • Safety assessed by vital signs: blood pressure (systolic blood pressure and diastolic blood pressure)
    • Time Frame: Up to 3 years
  • Number of participants with abnormal laboratory values and/or adverse events related to treatment
    • Time Frame: Up to 3 years

Secondary Measures

  • Death rate
    • Time Frame: Up to 3 years
  • Incidence of any vascular event
    • Time Frame: Baseline to Year 3
    • Vascular events include sudden death, death caused by the vascular event, non-fatal coronary hear disease (CHD), non-fatal cerebrovascular diseases, and non-fatal aorta and peripheral artery disease (PAD)
  • Change from baseline in Ankle-brachial index
    • Time Frame: Baseline to Year 3
  • Change from baseline in Pulse wave velocity
    • Time Frame: Baseline to Year 3
  • Change from baseline in Oxidative stress indices
    • Time Frame: Baseline to Year 3
    • Oxidative stress indices: superoxide dismutase and nitrotyrosine
  • Change from baseline in value of VCAM-1
    • Time Frame: Baseline to Year 3
    • VCMA-1: vascular cell adhesion molecule
  • Change from baseline in value of TNF-α
    • Time Frame: Baseline to Year 3
    • TNF: tumor necrosis factor

Participating in This Clinical Trial

Inclusion Criteria

  • Patients diagnosed as type 2 diabetes mellitus; – Patients who had the intima-media thickness (IMT) of carotid artery ≥1.1 mm in at least one side; – Patients who had results of aspartate aminotransferase, alanine aminotransferase, and serum creatinine no more than 1.5 times higher than the upper limit of normal; – Patients who had not cardio or cerebral vascular events within 3 months, including non-fatal myocardial infarction, stable and unstable angina pectoris, and non-fatal cerebral ischemic and hemorrhagic stroke; – Patients who had their systolic blood pressure <160 mmHg, diastolic blood pressure <100 mmHg, and glycated hemoglobin (HbA1c) <8.0%; – Patients who had not taken any medications with antithrombotic and antiplatelet effect within 3 months; Exclusion Criteria:

  • Patients who had peptic ulcer or active alimentary tract hemorrhage; – Patients who had a known allergy to prostacycline or non-steroid medications; – Patients who were pregnant, breast feeding, or had planned to be pregnant; – Patients who were attending or had attended any clinical studies within 3 months;

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Astellas Pharma Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Astellas Pharma Inc

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